FDA Inspection 1196666 — Siemens Healthineers AG
The FDA completed an inspection of Siemens Healthineers AG on Jan 26, 2023 in Forchheim. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 26, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Forchheim (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 3677 | 21 CFR 820.30(g) | Design validation - software validation not performed |
| 3696 | 21 CFR 820.100(b) | Documentation |